Chronic Weight ManagementPhase 2NCT06671821

Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects

A Phase 2 study testing HRS-7535 in people with Chronic Weight Management, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Weight Management
What is being tested?: HRS-7535
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteChina
Study dates: 20 Nov 2024to 28 Sep 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects, 18-65 years of age at the time of signing informed consent;
Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.

Who cannot join

Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039

Other trials in China

About this study

Official title: HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)

The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.

Conditions: Chronic Weight Management
Being tested: HRS-7535

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-7535Drug
HRS-7535

Study groups in NCT06671821
Study group	Role	What they receive
Group A	Experimental	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally Receives: Drug: HRS-7535
Group B	Experimental	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally Receives: Drug: HRS-7535
Group C	Experimental	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally Receives: Drug: HRS-7535
Group D	Experimental	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally Receives: Drug: HRS-7535

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with Treatment-emergent Adverse Event(AE)
Measured: During the 32-week open-label extension treatment period

Secondary outcomes (5)

Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Measured: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Measured: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Measured: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Measured: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Measured: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 202428 Sep 2025

First posted4 Nov 2024
Study start20 Nov 2024
Primary completion15 Aug 2025
Study completion28 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Weight ManagementStudies of the same condition, open and under way.
More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06671821
Sponsor's protocol ID: HRS-7535-202-Extension
Status last verified: Oct 2025
First submitted: 23 Oct 2024
Last updated: 17 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
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Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
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Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight

All Chronic Weight Management trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)
ClinicalTrials.gov ID: NCT06671821
Acronym / sponsor ID: HRS-7535-202-Extension
Conditions: Chronic Weight Management
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Nov 2024 (actual)
Primary completion: 15 Aug 2025 (actual)
Study completion: 28 Sep 2025 (actual)
First posted: 4 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Drug: HRS-7535Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Group B	Experimental	Drug: HRS-7535Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Group C	Experimental	Drug: HRS-7535Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Group D	Experimental	Drug: HRS-7535Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female subjects, 18-65 years of age at the time of signing informed consent;
Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.

Key exclusion criteria (3 listed)

Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-7535HRS-7535	Drug	Group A, Group B, Group C, Group D

Primary outcome

Number of participants with Treatment-emergent Adverse Event(AE)
Time frame: During the 32-week open-label extension treatment period

5 secondary outcomes

Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Weight Management

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
Obesity, Overweight
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS-7535 in people with Chronic Weight Management, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment-emergent Adverse Event(AE) (time frame: During the 32-week open-label extension treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06671821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.